STREERABLE PTCA GUIDEWIRE
FDA 510(k) clearance K011968 · decided 2001-07-25
Clearance details
- K-number
- K011968
- Device name
- STREERABLE PTCA GUIDEWIRE
- Applicant
- Lake Region Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-06-25
- Decision date
- 2001-07-25
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Chaska, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific Fort Guide Wire, Floppy Marker Wire, 300cm x 2 cm, REF 34949-02, for use recall (Z-1486-2009) | Boston Scientific Corporation | 2009-06-24 |
| Boston Scientific, Fort Guide Wire, Floppy, 300cm x 2 cm REF 34949-04, for use in intravas recall (Z-1487-2009) | Boston Scientific Corporation | 2009-06-24 |